Device and system for real-time gait modulation and methods of operation thereof

This application is a continuation of U.S. patent application Ser. No. 16/730,336, filed on Dec. 30, 2019, which claims priority to U.S. patent application Ser. No. 62/789,133 filed Jan. 7, 2019, the contents of which are incorporated herein by reference in their entireties.

This disclosure relates generally to the field of orthotics, more specifically, to improved devices, systems, and methods for real-time gait modulation.

Functional electrical stimulation (FES) is a treatment modality that applies electrical pulses to the neuromuscular system of a limb which has become paralyzed or weakened due to disease, injury, or aging. FES is commonly used as a treatment for patients exhibiting a condition known as drop foot. Patients suffering from drop foot often drag or lower their foot during the swing phase of the patient's gait cycle. To compensate for this dragging, a patient may swing their legs in a circular or exaggerated motion. This condition can lead to frequent falls and even short walks for such patients can be an exhaustive effort requiring excessive amounts of energy.

While orthotics and other gait modulation devices have been designed to treat gait-related impairments such as drop foot, such devices are often bulky and uncomfortable to wear. For example, certain such devices often comprise a rigid portion which can dig into the wearer's skin and is aesthetically displeasing. Moreover, other such devices require a heel sensor to be worn within the footwear of the user. This can lead to the user not being able to walk barefoot or in socks. This can also restrict the number of physical activities the user can undertake.

Furthermore, such devices often do not accurately calculate gait metrics based on real-time motion data. In addition, such devices often do not automatically generate stimuli based on real-time motion data. Moreover, some devices, such as those taught by U.S. Pat. No. 5,814,093, rely on a control method using tilt sensors. However, tilt parameters vary and require frequent tuning for appropriate stimulation timing. In addition, other devices, such as those taught by U.S. Pat. No. 6,507,757, rely on a control method whereby a footswitch coordinates stimulation timing by indicating foot-off and foot-strike. However, these types of devices rely on hardware being placed under the foot and are prone to false activation.

Therefore, improved devices, systems, and methods for real-time gait modulation are needed which address the challenges faced by current gait modulation devices. In addition, such a solution should provide added comfort, be easy to put on and take off by users, and provide data and metrics unavailable to users of current gait modulation devices. Moreover, such a solution should also not be overly complex and be cost-effective to manufacture.

Improved devices, systems, and methods for real-time gait modulation are disclosed. In one embodiment, a functional electrical stimulation (FES) device comprises one or more elastic wearable articles configured to be worn on a limb of a user. The device can also comprise a control unit comprising a wireless communication module, one or more processors, one or more memory units, a portable power supply, an electrical muscle stimulation (EMS) generator, and an inertial measurement unit (IMU) comprising at least a gyroscope or accelerometer. A housing of the control unit can be coupled to at least one of the one or more elastic wearable articles. The device further comprises one or more electrode arrays configured to be in electrical communication with the EMS generator. In some embodiments, at least one of the one or more electrode arrays is configured to be coupled to an inner surface of at least one of the one or more elastic wearable articles. The electrodes of the electrode array(s) can be in physical contact with the limb of the user when the device is worn by the user.

The one or more processors of the device can be programmed to execute instructions stored in the one or more memory units to retrieve gyroscope readings and accelerometer readings from the IMU, calculate a gait cycle percentage by inputting the gyroscope readings and accelerometer readings into a machine learning algorithm, and instruct the EMS generator to provide electrical stimulation to the nerves and muscles of the limb via the one or more electrode arrays based in part on the gait cycle percentage calculated.

In some embodiments, the one or more elastic wearable articles can comprise a first elastic sleeve and a second elastic sleeve. The first elastic sleeve can be configured to be worn on a thigh of the user and the second elastic sleeve can be configured to be worn on a lower leg of the user between a knee and an ankle of the user. The one or more electrode arrays can comprise at least a first upper leg array, a second upper leg array, a first lower leg array, and a second lower leg array. The first upper leg array and the second upper leg array can be coupled to the inner surface of the first elastic sleeve. The first upper leg array and the second upper leg array can be in physical contact with a skin surface in proximity to a hamstring of the user when the first elastic sleeve is worn on the thigh of the user. Moreover, the first lower leg array and the second lower leg array can be coupled to the inner surface of the second elastic sleeve. The first lower leg array and the second lower leg array can be in physical contact with the skin surface in proximity to a tibialis anterior of the user when the second elastic sleeve is worn on the lower leg of the user.

Alternatively, the one or more elastic wearable articles can comprise one elastic sleeve or cuff configured to be worn on a lower leg of the user between a knee and an ankle of the user. The one or more electrode arrays can comprise at least one first lower leg array and a second lower leg array coupled to the inner surface of the elastic sleeve. The first lower leg array and the second lower leg array can be in physical contact with the skin surface in proximity to a tibialis anterior of the user when the elastic sleeve is worn on the lower leg of the user.

As previously mentioned, the IMU of the device can further comprise an accelerometer. The one or more processors can be programmed to execute instructions stored in the one or more memory units to retrieve accelerometer readings from the IMU, map gyroscope readings and accelerometer readings to three-dimensional angles of at least one of a hip, a knee, and a foot of the user throughout a gait cycle, and determine at least one of a foot strike pattern, a foot inclination angle at initial contact, a tibia angle at loading response, a hip extension during late stance, a trunk lean, a heel eversion, a foot progression angle, a pelvic drop, a knee flexion during stance, a stride length, a knee window, a vertical displacement of the center mass, and a heel whip of the user based in part on the gait cycle percentage calculated, the gyroscope readings, the accelerometer readings, and the mapped three-dimensional angles.

The wireless communication module can be configured to wirelessly transmit readings and walking metrics calculated from the IMU and the gait cycle percentage to at least one of a client device of the user and a database accessible via a communication network. The one or more processors can be programmed to execute instructions stored in the one or more memory units to instruct the EMS generator to generate a plurality of asymmetrical biphasic square pulses for transmission to electrodes of the one or more electrode arrays to provide the electrical stimulation to the limb of the user.

The one or more processors can also be programmed to execute instructions stored in the one or more memory units to map the gyroscope readings and the accelerometer readings to two periodic functions using the machine learning algorithm. In some embodiments, the machine learning algorithm can comprise one or more multilayer perceptron neural networks. The one or more processors can be programmed to execute additional instructions to calculate a phase angle from the two periodic functions and convert the phase angle to the gait cycle percentage. The one or more processors can be programmed to execute instructions stored in the one or more memory units to smooth out the two periodic functions using one or more low-pass filter functions prior to calculating the phase angle.

A method of modulating a movement of a limb of a user is also disclosed. The method comprises retrieving, using one or more processors, gyroscope readings and accelerometer readings from an inertial measurement unit (IMU). The one or more processors and the IMU can be part of a control unit further comprising a wireless communication module, one or more memory units, a portable power supply, and an electrical muscle stimulation (EMS) generator. A housing of the control unit can be coupled to at least one of one or more elastic wearable articles configured to be worn on the limb of the user.

The method can further comprise calculating, using the one or more processors, a gait cycle percentage by inputting the gyroscope readings and the accelerometer readings into a machine learning algorithm and instructing the EMS generator to provide electrical stimulation to the limb of the user via one or more electrode arrays based in part on the gait cycle percentage calculated. At least one of the one or more electrode arrays can be coupled to an inner surface of at least one of the one or more elastic wearable articles. The electrodes of the one or more electrode arrays can be in physical contact with the limb of the user when the one or more elastic wearable articles are worn by the user.

The method further comprises mapping, using the one or more processors, the gyroscope and accelerometer measurements to two periodic functions using the machine learning algorithm, smoothing out the two periodic functions using one or more low-pass filter functions, and calculating a phase angle from the two periodic functions, and converting the phase angle to the gait cycle percentage. The machine learning algorithm can comprise one or more multilayer perceptron neural networks.

In some embodiments, the one or more elastic wearable articles can comprise a first elastic sleeve and a second elastic sleeve. The first elastic sleeve can be configured to be worn on a thigh of the user and the second elastic sleeve can be configured to be worn on a lower leg of the user between a knee and an ankle of the user. The one or more electrode arrays can comprise at least a first upper leg array, a second upper leg array, a first lower leg array, and a second lower leg array. The first upper leg array and the second upper leg array can be coupled to the inner surface of the first elastic sleeve. The first upper leg array and the second upper leg array can be in physical contact with a skin surface in proximity to a hamstring of the user when the first elastic sleeve is worn on the thigh of the user. Moreover, the first lower leg array and the second lower leg array can be coupled to the inner surface of the second elastic sleeve. The first lower leg array and the second lower leg array can be in physical contact with the skin surface in proximity to a tibialis anterior of the user when the second elastic sleeve is worn on the lower leg of the user.

Alternatively, the one or more elastic wearable articles can comprise one elastic sleeve or cuff configured to be worn on a lower leg of the user between a knee and an ankle of the user. The one or more electrode arrays can comprise a first lower leg array and a second lower leg array coupled to the inner surface of the elastic sleeve. At least one of the first lower leg array and the second lower leg array can be in physical contact with the skin surface in proximity to a tibialis anterior of the user when the elastic sleeve is worn on the lower leg of the user.

The method can further comprise transmitting, using the wireless communication module, readings from the IMU and the gait cycle percentage calculated to at least one of a client device of the user and a database accessible via a communication network. Moreover, the method can further comprise instructing the EMS generator to generate a plurality of asymmetrical biphasic square pulses for transmission to electrodes of the one or more electrode arrays to provide the electrical stimulation to the nerves and muscles of the limb of the user.

The method can further comprise mapping gyroscope readings and accelerometer readings to three-dimensional angles of at least one of a hip, a knee, and a foot of the user throughout a gait cycle. The method can also comprise determining at least one of a foot strike pattern, a foot inclination angle at initial contact, a tibia angle at loading response, a hip extension during late stance, a trunk lean, a heel eversion, a foot progression angle, a pelvic drop, a knee flexion during stance, a stride length, a knee window, a vertical displacement of the center mass, and a heel whip of the user based in part on the gait cycle percentage calculated, the gyroscope readings, the accelerometer readings, and the mapped three-dimensional angles.

illustrates a front view of one embodiment of a functional electrical simulation (FES) devicefor real-time gait modulation. The devicecan comprise one or more elastic wearable articles configured to be worn on a limb of a user. In some embodiments, the elastic wearable articles can comprise one or more elastic sleeves such as wearable compression sleeves. In other embodiments, the one or more elastic wearable articles can comprise elastic straps, elastic wrappings, elastic bands, or elastic clothing such as compression leggings, pants, shorts, socks, shirts, vests, bras, or a combination thereof. The elastic wearable article can be a compliant or pliant wearable article configured to cover, envelope, circumscribe, and/or extend over at least a segment of the user's limb(s). The elastic wearable article can be made in part of a lightweight synthetic fabric such as spandex (also known as Lycra® or elastane). The elastic wearable article can also comprise other synthetic or organic fabrics including nylon, polyester, cotton, or a combination thereof. More specifically, the nylon can be Cordura® nylon, oxford cloth nylon, or a combination thereof. In some embodiments, the elastic wearable articles can be made of materials having moisture wicking properties.

It has been discovered by the applicant that integrating an FES devicewith a compression sleeve or other compressive wearable article can provide the added benefit of stabilizing the muscles of a user having a walking or mobility impairment. For example, an FES devicedesigned as a compression sleeve or other compressive wearable article can improve blood flow and stabilize muscles in addition to stimulating such muscles.

As shown in, the devicecan comprise two elastic sleeves (e.g., leg sleeves) including a first elastic sleeveand a second elastic sleeve. The first elastic sleevecan be configured to be worn on or cover at least part of an upper leg of the user. For example, the first elastic sleevecan be configured to be worn on or cover at least part of a thigh of the user. The second elastic sleevecan be configured to be worn on or cover at least part of a lower leg of the user. For example, the second elastic sleevecan be configured to be worn on or cover at least part of the lower leg of the user between a knee (or patella/kneecap) and an ankle of the user. As shown in, the knee of the user can be exposed when the devicecomprises two elastic sleeves and the first elastic sleeveis worn on a lower leg of the user and the second elastic sleeveis worn on an upper leg of the user. One advantage of this design is the freedom of motion provided the user when the knee of the user is not constricted.

In the embodiments shown in, the first elastic sleeveand the second elastic sleevecan be worn on the same leg of the user. In other embodiments not shown in the figure but contemplated by this disclosure, the first elastic sleeveand the second elastic sleevecan be worn on different legs of the user or on each leg of the user.

In other embodiments, the devicecan comprise one elastic sleeve covering only the upper leg or only the lower leg of the user. In these embodiments, the devicecan comprise only one of the first elastic sleeveor the second elastic sleeve. In additional embodiments not shown in the figures but contemplated by this disclosure, the devicecan comprise one long elastic sleeve covering part of the upper leg (e.g., part of the thigh) and part of the lower leg (e.g., part of the lower leg between the knee and the ankle) of the user.

The devicecan also comprise a control unitand one or more electrode arrayscoupled to the elastic wearable article. As shown in, the control unitcan be detachably carried or detachably coupled to the elastic wearable article (e.g., any of the first elastic sleeveor the second elastic sleeve). For example, the control unitcan be detachably carried by the elastic wearable article by being stored, positioned, or housed within a pocket or enclosureof the elastic wearable article. As a more specific example, the pocket or enclosurecan be a zipper pocket sewn into or onto the elastic wearable article (e.g., any of the first elastic sleeveor the second elastic sleeve). In other embodiments, the pocket or enclosurecan be a pocket, sachet, or enveloped enclosure configured to be closed and opened via a hook-and-loop fastener (e.g., Velcro®), a snap button fastener, a fold covering, a magnetic fastener, or a combination thereof. Althoughshows the pocket or enclosuresewn or otherwise coupled to the second elastic sleeve, it is contemplated by this disclosure that the pocket or enclosurecan also be sewn or otherwise coupled to the first elastic sleeveand the control unitcan be detachably coupled or carried by the first elastic sleeve. The pocket or enclosurecan be sized to tightly or securely house or contain the control unitsuch that the control unitdoes not inadvertently shift or rock within the pocket or enclosure.

The control unitcan be detachably coupled or carried by the elastic wearable article to allow the elastic wearable article to be washed or cleaned when the control unitis removed. In addition, the control unitcan be detachably coupled or carried by the elastic wearable article to allow for the control unitto be updated or new control unitsto be used with legacy wearable articles. In other embodiments not shown in the figures but contemplated by this disclosure, the control unitcan be detachably coupled to the outer surface or inner surface of the elastic wearable article via adhesives, a magnetic coupling mechanism, a latch or clasp, a snap fitting, or a combination thereof.

As shown in, the control unitcan be positioned on the front or anterior side of the lower leg of the user and below the knee of the user. For example, the control unitcan be securely housed or held by a pocket or enclosurepositioned on the front or anterior side of the lower leg of the user slightly below the knee of the user. Since the control unitis housed or encapsulated by the pocket or enclosure, the control unitis shown inin broken lines.

As will be discussed in more detail in the following sections, the control unitcan comprise at least a gyroscope, an accelerometer, a magnetometer, or a combination thereof (see). One unexpected discovery made by the applicant is that gyroscope readings obtained from a gyroscopepositioned on the anterior side of the lower leg of the user below the knee of the user results in more robust input data that can be introduced to a machine learning algorithm(see) to map to periodic functions used to calculate a more accurate gait cycle percentage(see).

In other embodiments not shown in the figures but contemplated by this disclosure, the control unitcan also be positioned anywhere on the user's leg, including on the back of the lower leg of the user (in proximity to the calf or gastrocnemius) of the user. Moreover, the control unitcan also be positioned on the front of the upper leg of the user above the patella or knee of the user.

The devicecan also comprise one or more electrode arraysin electrical communication with the control unit. For example, the one or more electrode arrayscan be in electrical communication with an electrical muscle stimulation (EMS) generator(see) of the control unit. The one or more electrode arrayscan be in electrical communication with the control unitvia a number of conductive wires, electrical traces, conductive fibers, or a combination thereof. The conductive wires, electrical traces, conductive fibers, or a combination thereof can be embedded within layers of the elastic wearable article or interwoven with fibers used to make the elastic wearable article.

Each of the electrode arrayscan be comprised of a plurality electrodesin proximity to other electrodes. For example, as shown in, the electrodesof each of the electrode arrayscan be arranged in a grid pattern. In other embodiments, the electrodesof each of the electrode arrayscan be arranged in a circular pattern, an oval pattern, a spiral pattern, a linear pattern, a zig-zig pattern, a rhombus pattern, a triangular pattern or another polygonal pattern, or a combination thereof.

Each of the electrodescan comprise a number of layers including a substrate or contact layer, one or more conductive layers, and a connector layer. The conductive layers can be made in part of a metal, metal chloride, or metal oxide. For example, the conductive layers can be made in part or comprise silver or silver chloride. In some embodiments, a silver mesh layer can be shared by all of the electrodesof one electrode array. The substrate or contact layer can be biocompatible polymeric layer. The substrate or contact layer can physically contact the skin surface of the user. For example, the substrate or contact layer can comprise a layer of cross-linked copolymers such as a hydrogel layer. In these and other embodiments, the substrate or contact layer can also require that a conductive gel or conductive solution coat or cover the skin surface of the user, the substrate or contact layer, or a combination thereof before operating the device. In these and other embodiments, the substrate or contact layer can be a sponge made conductive with an ionic solution. The connector layer can comprise a number of receptors or connectors configured to connect the electrodesto wires, traces, or fibers leading to components within the control unit.

The electrodesof the one or more electrode arrayscan be coupled to an inner surface of the elastic wearable article (e.g., the first elastic sleeve, the second elastic sleeve, or a combination thereof). For example, the electrode arrayscan be coupled to the inner surface of the elastic wearable article by adhesives, clips, straps, hook-and-loop fasteners, stitches (e.g., sewn into the elastic wearable article), or a combination thereof. The electrodescan be positioned such that the substrate or contact layer of the electrodesis in physical contact with a skin surface of the user when the user wears or puts on the elastic wearable article. In these and other embodiments, any of the electrodesof the electrode arrayscan be detached or separated from the elastic wearable article. This can allow the elastic wearable article to be washed or cleaned and allow for worn or malfunctioning electrodesto be replaced.

illustrates that the second elastic sleevecan comprise at least a first lower leg arrayand a second lower leg array. The first lower leg arraycan be positioned or arranged superior to or above the second lower leg arraywhen the second elastic sleeveis worn by the user. Although two electrode arraysare shown coupled to the second elastic sleeve, it is contemplated by this disclosure that any number of electrode arrayscan be coupled to the second elastic sleeveincluding, but not limited to, three electrode arrays, four electrode arrays, five electrode arrays, six electrode arrays, seven electrode arrays, eight electrode arrays, nine electrode arrays, and ten or more electrode arraysdistributed over various neuromuscular targets on the body of the user.

illustrates a side perspective view of the deviceshown in. As shown in, the first lower leg arrayand the second lower leg arraycan be positioned in proximity to a tibialis anterior muscle of the user when the second elastic sleeveis worn on the lower leg of the user (e.g., between the knee or patella of the user and the ankle). For example, the first lower leg arrayand the second lower leg arraycan be positioned such that the substrate or contact surface of the electrodeswithin these arrays physically contact the skin surface in proximity to a tibialis anterior muscle of the user. Since the tibialis anterior muscles are innervated in part by the deep fibular nerve (also known as the deep peroneal nerve), providing electrical stimulation to the deep fibular nerve (or deep peroneal nerve) via electrodesof the first lower leg array, the second lower leg array, or a combination thereof positioned in proximity to the tibialis anterior muscles can cause dorsiflexion of the foot of the user. As will be discussed in more detail in the following sections, terminating electrical stimulation to the deep fibular nerve (or deep peroneal nerve) can result in the user relaxing the dorsiflexion motion.

illustrates a rear view of the deviceshown in. As depicted in, the devicecan further comprise a first upper leg arrayand a second upper leg array. At least one of the first upper leg arrayand the second upper leg arraycan be coupled or otherwise attached to an inner surface of the first elastic sleeve. The first upper leg arraycan be positioned above or superior to the second upper leg arraywhen the first elastic sleeveis worn by the user. The first upper leg arrayand the second upper leg arraycan be positioned in proximity to a hamstring muscle of the user when the first elastic sleeveis worn on a thigh of the user. For example, the first upper leg arrayand the second upper leg arraycan be positioned such that the substrate or contact surface of the electrodeswithin these arrays physically contact the skin surface in proximity to the hamstring muscles of the user. The hamstring muscles are innervated in part by the tibial nerve and the sciatic nerve. Providing electrical stimulation to the tibial nerve, the sciatic nerve, or a combination thereof via electrodesof the first upper leg array, the second upper leg array, or a combination thereof in proximity to the hamstring muscles can cause plantarflexion of the foot of the user. Terminating electrical stimulation to such nerve(s) can result in the user ceasing the plantarflexion motion.

As will be discussed in more detail in the following sections, selective activation of electrodesof one or more electrode arrays(e.g., the first upper leg array, the second upper leg array, the first lower leg array, the second lower leg array, or a combination thereof) can provide electrical stimulation to the neuromuscular system of the leg and foot of the user and cause the leg and foot of the user to move in such a way as to enhance or correct (or make up for any impairments of) the gait of the user.

Although two electrode arraysare shown coupled to the first elastic sleeve, it is contemplated by this disclosure that any number of electrode arrayscan be coupled to the first elastic sleeveincluding, but not limited to, three electrode arrays, four electrode arrays, five electrode arrays, six electrode arrays, seven electrode arrays, eight electrode arrays, nine electrode arrays, and ten or more electrode arrays.

Moreover,illustrates that the electrodesof the first upper leg arrayand the second upper leg arraycan be bigger in size (i.e., larger electrode contact surface area or the arrays cover more skin surface area) than the electrodesof the first lower leg arrayor the second lower leg array. The electrodesof the first upper leg arrayand the second upper leg arraycan be bigger in size due to the size disparity between the hamstring muscles and the tibialis anterior muscles.

illustrate other embodiments of the functional electrical stimulation devicefor real-time gait modulation. The devicecan comprise one or more elastic wearable articles configured to be worn on a limb of a user. In these embodiments, the elastic wearable articles can comprise a strap or cuffto be worn on a leg of the user.

The strap or cuffcan be made in part of a semi-rigid thermoplastic polyurethane (TPU) core covered by a textile or fabric-type material(see). In some embodiments, the textile or fabric-type material can be a mesh fabric.

The strap or cuffcan be secured to the limb of the user using a fastening mechanism. In some embodiments, the fastening mechanismcan comprise an elastic strap or clip. In these and other embodiments, the fastening mechanismcan comprise a magnetic latching mechanism. The fastening mechanismcan be configured such that the fastening mechanismcan be fastened or unfastened with a single hand of the user. One rationale for a fastening mechanismthat is operable by a single hand of the user is that many users of the devicemay have hemiparesis, a condition whereby the ipsilateral hand may have a similar degree of paralysis as the leg on which the strap or cuffis to be worn.

As shown in, the control unitcan be detachably or removably coupled to an exterior surfaceor outer side of the device. For example,illustrates that the control unitcan be detachably or removably coupled to the devicevia snap fastenerspositioned on the exterior surfaceof the strap or cuff.

also illustrates that the devicecan comprise one or more electrode arraysin electrical communication with the control unit. For example, the electrodesof the electrode array(s)can be in electrical communication with the EMS generator(see) of the control unit. The electrodesof the electrode array(s)can be in electrical communication with the control unitvia a number of conductive leads or lead cables, electrical traces, conductive fibers, or a combination thereof.

The electrode arrayscan comprise an upper leg electrode arrayand a lower leg electrode array. The control unitcan control a plurality of electrode arraysconnected by leads or lead cablesto the control unit. The electrode arrayscan be distributed across different muscle groups of the user. The deviceand methods disclosed herein can allow any muscle to be stimulated with appropriate timing relative to the gait cycle. The devicecan also be configured to output to one or more stimulation channels (e.g., two independent stimulation channels). For example, one of the channels can be electrically coupled to or in electrical communication with electrodesof the lower leg electrode arrayvia leads embedded within the elastic wearable article (e.g., a fabric portion of the cuff) to stimulate the tibialis anterior muscle or common peroneal nerve. Also, in this example, a second channel can be electrically coupled to or in electrical communication with the electrodesof the upper leg electrode arrayvia lead cablesextending from the control unit. The upper leg electrode arraycan be used to stimulate the hamstring muscles or the tibial nerve or sciatic nerve of the user. The two channels can be programmed independently such that amplitude, waveform, and gait phase (on-off timing) can all be specified independently.

In some embodiments, the control unitcan comprise a user interface or wired control panel comprising a plurality of multi-colored LED lights and at least one push-button or switch configured to allow the deviceto be turned on/off and stimulation settings (e.g., amplitude, frequency, and mode) to be adjusted. In certain embodiments, the control panel can comprise a plurality of push-buttons or switches (e.g., three push-buttons or switches). In these and other embodiments, the devicecan be controlled by a client device (e.g., a smartphone, tablet computer, or smartwatch) of the user in wireless communication with the control unit. A user can turn on/off the device, adjust the stimulation settings (e.g., amplitude, frequency, and mode), review usage metrics, and upload data to a database using the client device in wireless communication with the control unit.

illustrate the FES devicecomprising the strap or cuffworn on a leg of the user. The strap or cuff can be worn on a lower leg of the user between a knee and an ankle of the user (e.g., right under the knee of the user). An upper leg electrode arrayand a lower leg electrode arraycan be electrically coupled to or in electrical communication with the control unitvia one or more lead cablesor leads. The upper leg electrode arraycan be adhered (e.g., via biocompatible adhesives, gels, stick pads, straps, bands, etc.) to the hamstring muscles, the quadricep muscles, or the rectus femoris muscle of the user. As previously discussed, the hamstring muscles are innervated in part by the tibial nerve and the sciatic nerve. Providing electrical stimulation to the tibial nerve, the sciatic nerve, or a combination thereof via electrodesof the upper leg arraycan cause plantarflexion of the foot of the user.

The lower leg electrode arraycan be adhered (e.g., via biocompatible adhesives, gels, stick pads, straps, bands, etc.) to the tibialis anterior muscles of the user. As previously discussed, the tibialis anterior muscles are innervated in part by the deep fibular nerve (also known as the deep peroneal nerve). Providing electrical stimulation to the deep fibular nerve (or deep peroneal nerve) via electrodesof the lower leg arraycan cause dorsiflexion of the foot of the user. Terminating such electrical stimulation to the deep fibular nerve (or deep peroneal nerve) can cause the user to relax the dorsiflexion motion.

are schematic drawings showing rear and front views, respectively, of muscles of the human leg. Althoughillustrate the electrode arrayspositioned in proximity to the tibialis anterior and hamstring muscles of the user, it is contemplated by this disclosure that one or more electrode arrayscan also be positioned in proximity to the gastrocnemius (or calf) muscle, the quadricep muscles, and the rectus femoris muscle of the user. For example, at least one electrode arraycan be coupled or otherwise attached to an anterior portion or side of the inner surface of the first elastic sleeve. Also, for example, at least one electrode arraycan be coupled or otherwise attached to a posterior portion or side of the inner surface of the second elastic sleeve. Moreover, it is contemplated by this disclosure that any of the muscles shown in, and nerves innervating such muscles, can be stimulated by electrode arrayscoupled or otherwise attached to the elastic wearable article.